NexBio announces the completion of its First-In-Man clinical trial of DAS181 (Fludase), an investigational drug candidate for influenza. The single-dose, escalating phase-I study completed in December 2008 was designed to assess DAS181 safety in healthy subjects.
The study drug was well tolerated at all dose levels. DAS181 is a novel broad-spectrum drug candidate for prophylaxis and treatment of respiratory infections by all variations of influenza virus, including the types of the virus that may cause a potential influenza pandemic. In addition, DAS181 also has the potential for prophylaxis and treatment of influenza-like illness due to other respiratory viruses, including the parainfluenza virus which may cause serious respiratory illness similar to influenza for which there is no approved vaccine or therapeutic. The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
DAS181, a recombinant fusion protein, inactivates viral receptors on the cells of the human respiratory tract, thereby preventing influenza and parainfluenza viruses from infecting the human body or from amplifying in infected individuals. DAS181 effectively inhibits numerous strains of influenza and parainfluenza virus in cell culture and in animal models. Unlike current antiviral compounds and vaccines, DAS181 targets human host receptors, not virus components, and thus carries a reduced risk of drug resistance compared with the currently available antiviral drugs. Extensive, prolonged non-clinical studies have not shown the development of any meaningful resistance.
To strengthen DAS181 clinical development, NexBio announced the hiring of Ronald B Moss, as NexBio's executive vice president of Clinical Development & Medical Affairs. Dr Moss brings 22 years of research and clinical experience, including 15 years of pharmaceutical drug development experience ranging from phase-1 to NDA, and extensive expertise in clinical, regulatory and quality affairs.
"I look forward to the opportunity to execute the critical tasks that are required for the successful clinical development of DAS181 at NexBio. DAS181 represents a vital new approach to preventing and treating pandemic influenza," said Dr Moss. "As a practicing physician, I also appreciate the urgent medical need for a new, broad-spectrum agent to address seasonal influenza-like illness, one that combines the best features of vaccines and current antiviral compounds. My clinical development experience will help to ensure that DAS181 development is done in a safe, careful, and timely manner."
To further broaden the clinical expertise to support DAS181 development, NexBio has recently formed a Clinical Advisory Board chaired by Andrew T Pavia, FIDSA, FAAP. Dr Pavia is the George and Esther Gross Presidential professor and chief of the Division of Paediatric Infectious Diseases at the University of Utah Health Sciences Center.
"There is a tremendous need for new antivirals for both seasonal and pandemic influenza," said Dr Pavia. "The successful record of antiviral drug development for HIV has shown us the tremendous potential of drugs to treat fast mutating viruses, but also the challenge of having a clinical development program that adapts to the clinical need."
Influenza is a highly infectious acute respiratory disease that has plagued the human race since ancient times. It is characterized by recurrent annual epidemics and periodic major worldwide pandemics. Annual epidemics cause approximately 300,000 hospitalizations and 36,000 deaths in the United States alone. In the 20th century, at least three influenza pandemics have occurred (1918, 1957, and 1968). Together, they caused millions of deaths. Since 2003, the avian influenza H5N1 has spread to hundreds of poultry farms in Asia, Europe, and Africa. Based on the latest data from the World Health Organization, 391 people have been infected by the virus in 15 countries resulting in 247 deaths.
NexBio is a privately held development-stage biopharmaceutical company located in San Diego.